Systems Engineer - Assay Development & Validation

F. Hoffmann-La Roche AG; Tucson (AZ); On-site; USD 73,000 - 135,000; Full time

Job summary

Roche Tissue Diagnostics in Arizona seeks a Systems Engineer to drive requirements definition, risk management, and verification & validation across projects. You will own deliverables and influence design trade-offs to meet regulatory expectations.

You will collaborate with R&D, Manufacturing, Quality, and Regulatory teams to ensure traceability and robust validation across the system lifecycle. A background in assay development and familiarity with FDA/ISO standards is preferred.

Qualifications

• Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with relevant experience.
• Experience in assay development at a medical device company.
• Familiarity with FDA/ISO regulatory standards for diagnostics.

Responsibilities

• Define requirements and drive system architecture across the project lifecycle.
• Perform risk management and verification & validation activities.
• Collaborate with R&D, Marketing, Operations, Quality, and Regulatory teams.

Skills

Systems engineering

Requirements elicitation

Risk analysis (FMEA)

V&V test strategy

Regulatory familiarity

Education

Bachelor's degree in Engineering, Biomedical Sciences, or related technical field

Tools

RETINA (Requirements & Test Integration Application)

LucidSpark

LucidChart

Job description

Roche Tissue Diagnostics in Arizona seeks a Systems Engineer to drive requirements definition, risk management, and verification & validation across projects. You will own deliverables and influence design trade-offs to meet regulatory expectations.

You will collaborate with R&D, Manufacturing, Quality, and Regulatory teams to ensure traceability and robust validation across the system lifecycle. A background in assay development and familiarity with FDA/ISO standards is preferred.